FDA.reportPublic FDA data

Engage Partial Knee System

Primary DI
B6951520020000
Brand
Engage Partial Knee System
Company
Engage UNI LLC
Model
1-52002-000
Device description
General Tray 2
Published
2020-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190439000Engage™ Partial Knee SystemEngage Uni, LLC2019-11-21NJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6951520020000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
833-364-2432info@engagesurgical.com
1-800-238-7538gudid@smith-nephew.com

Regulatory Flags#

DUNS number
088177182
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6951520010000Engage Partial Knee System1-52001-0002020-07-10
B6951520040000Engage Partial Knee System1-52004-0002020-07-10
B6951520050000Engage Partial Knee System1-52005-0002020-07-10
B6951520100000Engage Partial Knee System1-52010-0002020-07-10
B6951500780000Engage Partial Knee System1-50078-0002021-04-09
B6951510040050Engage Partial Knee System1-51004-0052021-03-01
B6951510050050Engage Partial Knee System1-51005-0052021-03-01
B6951510380000Engage Partial Knee System1-51038-0002021-03-01
B6951510390000Engage Partial Knee System1-51039-0002021-03-01
B6951500600210Engage Partial Knee System1-50060-0212020-10-02
B6951100035000Engage Partial Knee System1-10003-5002020-07-10
B6951100131090Engage Partial Knee System1-10013-1092020-07-10
B6951100131100Engage Partial Knee System1-10013-1102020-07-10
B6951100131110Engage Partial Knee System1-10013-1112020-07-10
B6951100131130Engage Partial Knee System1-10013-1132020-07-10
B6951100132090Engage Partial Knee System1-10013-2092020-07-10
B6951100132100Engage Partial Knee System1-10013-2102020-07-10
B6951100132110Engage Partial Knee System1-10013-2112020-07-10
B6951100132130Engage Partial Knee System1-10013-2132020-07-10
B6951100133090Engage Partial Knee System1-10013-3092020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613327127423INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127485INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HSX2017-11-24
07613327049305AvonHowmedica Osteonics Corp.HSX2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24